Efficacy of SALI-10 Oral Probiotics in Experimental Gingivitis

ConditionGingivitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOstia Sciences

About this trial

Gingivitis is among the most prevalent oral diseases worldwide, affecting an estimated 50-90% of adults. It is a reversible condition primarily caused by microbial plaque accumulation on teeth and gingival surfaces, which triggers inflammation. Standard care emphasizes plaque reduction through oral hygiene, and research shows gingivitis can be reversed once hygiene resumes. The classic experimental gingivitis (EG) model developed in 1965 by Löe and Silness demonstrated the direct link between plaque buildup and gingival inflammation, further confirming that gingival health can be restored after resuming proper care.

Microbial ecology shifts are central to gingivitis pathogenesis. In health, the oral microbiome is dominated by gram-positive Streptococcus species. With plaque accumulation, microbial communities transition to gram-negative periopathogens such as Porphyromonas, Tannerella, Treponema, and Prevotella. This dysbiosis provokes heightened inflammation, tissue damage, and, in susceptible individuals, progression to periodontitis. Individual variability in the inflammatory response has been associated with differences in the presence and activity of beneficial streptococci. Certain strains of Streptococcus salivarius produce lantibiotics called salivaricins-polycyclic antimicrobial peptides containing lanthionine residues. Salivaricins inhibit oral pathogens and have been investigated for their antimicrobial and probiotic properties, particularly in the context of rising antibiotic resistance. Probiotic S. salivarius strains isolated from healthy individuals have demonstrated safety and antimicrobial potential in previous studies, supporting their use in preventing oral and respiratory infections.

A strain of S. salivarius designated SALI-10 produces a lantibiotic, Salivaricin 10, and is being evaluated as a candidate for gingivitis prevention. This strain is hypothesized to (1) help stabilize populations of beneficial streptococci during plaque accumulation, (2) competitively inhibit periopathogens such as Porphyromonas and Prevotella, and (3) suppress the dysbiotic shift toward gram-negative dominance. By contributing to microbial balance and reducing inflammatory triggers, SALI-10 may support resilient host-microbe interactions associated with gingival health. This approach may offer a dual antimicrobial and microbiome-stabilizing strategy with relevance to gingivitis management and longer-term periodontal health.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female volunteers aged 18-70 years

In good general health, ASA I

No clinical signs of gingival inflammation at >90% of sites observed

Absence of Periodontal Pockets, Probing Depth (PD) < 3.0 mm on all teeth/site

Disqualifiers

Presence of orthodontic bands.

Presence of partial or full dentures.

Tumour(s) of the soft or the hard tissues of the oral cavity.

Cavitated carious lesions requiring immediate restorative treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 6B SALI-10

    Dietary supplement

    Lozenges containing 6B CFUs of probiotic S. salivarius SALI-10

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PlaceboNo intervention 0 interventions
Group B: SALI-10Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in percentage of sites with bleeding on probing (BOP)

Bleeding on probing (BOP) will be assessed at six sites per tooth using a UNC-15 periodontal probe. The proportion of bleeding sites (% of total sites) will be calculated for each participant. Group mean ± SD change from baseline will be reported. Scale: 0-100 %; lower values = less gingival inflammation.

Time frame
Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).

Secondary outcomes

1

Change in oral neutrophil (oPMN) count per 10 mL unstimulated saliva

Unstimulated saliva (10 mL) will be collected, centrifuged, and stained with acridine orange. Neutrophils will be counted using fluorescence microscopy and a hemocytometer. Results expressed as total PMNs × 10³ cells / 10 mL.

Time frame
Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).
2

Change in concentration of cytokines (IL-1β, IL-6, MMP-8) in gingival crevicular fluid (pg/mL)

Gingival crevicular fluid (GCF) will be collected using Periopaper strips and analyzed with bead-based multiplex immunoassays (Luminex). Mean concentrations (pg/mL) will be reported per participant; lower values indicate reduced local inflammation.

Time frame
Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).
3

Change in relative abundance of periodontal and commensal bacteria measured by quantitative PCR and shotgun metagenomics

DNA extracted from subgingival plaque and tongue swabs will be analyzed for P. gingivalis, F. nucleatum, T. forsythia, P. micra and S. salivarius SALI-10. Abundance expressed as ΔCt relative to total 16S rRNA gene copies. Metagenomic analysis will evaluate community shifts.

Time frame
Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).
4

Change in concentration of volatile sulfur compounds (VSCs) in exhaled air measured by Halimeter (ppb)

Halitosis will be quantified using a calibrated Halimeter (Interscan Corp.). Three consecutive breath readings will be averaged per visit. Results reported in parts per billion (ppb); lower values indicate improved oral odor.

Time frame
Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).

Other outcomes

Sponsors and contacts

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Ostia Sciences

Lead sponsor

University of Toronto

Collaborator